Roche Diagnostics Corporation, Premarket Approval of Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc for use on the Elecsys® 2010 Immunoassay Analyzer P100032, Approved 6/27/11

 
Docket ID: FDA-2011-M-0503
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Roche Diagnostics Corporation, Premarket Approval of Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc for use on the Elecsys® 2010 Immunoassay Analyzer P100032, Approved 6/27/11
Keyword(s): Analyzer P100032, Elecsys® 2010 Immunoassay , PreciControl Anti-HBc , Elecsys® Anti-HBc
Type: Nonrulemaking
Center: CDRH
Docket Item Code: M
 

Primary Documents

View All  (3)
Comment Period Closed
Notice
Posted: 01/13/2012
ID: FDA-2011-M-0503-0003
Comment Period Closed
Notice
Posted: 08/04/2011
ID: FDA-2011-M-0503-0001

Supporting Documents

 
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